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OpenTrials
Completed

NCT Number: NCT01279954

Abatacept in the Treatment of Uveitis

The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.

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Key information

Conditions

Uveitis Eye Diseases Uveal Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with vision-threatening autoimmune uveitis
  • failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects

Exclusion criteria

  • serious concomitant illness that could interfere with the subject's participation

Treatment and study plan

Abatacept

Drug

Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.

Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.

Other names: orencia

Primary outcomes

  1. Adverse Events

    Time frame: 2 years

    number of participants with adverse events

Secondary outcomes

  1. Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity

    Time frame: Week 24

    improvement by 2 or more lines of best-corrected visual acuity With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.

  2. Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%

    Time frame: Week 24

    Reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.

  3. Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods

    Time frame: Week 24

    Reduction of AC cellular activity and/or vitreous haze by 2 grades. Reduction of chorioretinal infiltrates or reduction of retinal vasculitis. Reduction of cystoid macular edema and/or retinal inflammation. With the outcome measure being at 24 weeks, only one group is analyzed. All the subjects received open-label abatacept at 10 mg/kg during the first 24 weeks.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 20, 2011
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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